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Platinum-based chemotherapy

Cisplatin for Anal Cancer (InterAACT Trial)

Phase 2
Waitlist Available
Led By Cathy Eng
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial is comparing two different chemotherapy drug combinations to see which one is more effective in treating anal cancer.

Eligible Conditions
  • Anal Cancer
  • Anal Canal Cancer
  • Anal Canal Carcinoma
  • Anal Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best ORR defined as the percentage of patients achieving confirmed partial (PR) or complete responses (CR) as per RECIST v1.1
Secondary study objectives
Anti-tumor activity and magnitude of response
Best ORR of non-irradiated lesions defined as the percentage of patients achieving confirmed PR or CR as per RECIST v1.1 of non-irradiated sites of disease
Changes in QOL
+7 more
Other study objectives
Biomarkers, Tumor

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (paclitaxel, carboplatin)Experimental Treatment4 Interventions
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (cisplatin, fluorouracil or capecitabine)Experimental Treatment5 Interventions
Patients receive cisplatin IV over 1-4 hours on day 1 and fluorouracil IV continuously over 24 hours on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with complications associated with the central venous access which prevent further infusion of fluorouracil and only after discussion with the Chief Investigator receive capecitabine BID on days 1-4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Capecitabine
2013
Completed Phase 3
~3970
Cisplatin
2013
Completed Phase 3
~2360
Fluorouracil
2014
Completed Phase 3
~11700
Paclitaxel
2011
Completed Phase 4
~5810

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
119 Previous Clinical Trials
178,956 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,909 Total Patients Enrolled
Cathy EngPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
352 Total Patients Enrolled
~10 spots leftby Sep 2025
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